Flawed, scandalous trials tank FDA expert support for MDMA therapy

Bias, missing data, and claims of a new-age cult overshadow positive patient results.

Jun 5, 2024 - 08:50

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Flawed, scandalous trials tank FDA expert support for MDMA therapy

After a remarkably sensational regulatory drug review, advisers for the Food and Drug Administration on Tuesday voted overwhelmingly against approving midomafetamine (MDMA, aka ecstasy or molly) as part of therapy for post-traumatic stress disorder.

In a response to the question, "Do the available data show that the drug is effective in patients with posttraumatic stress disorder?" advisers voted 9 "no" to 2 "yes" against MDMA.

In response to the second question, "Do the benefits of midomafetamine with FDA’s proposed risk evaluation and mitigation strategy (REMS) outweigh its risks for the treatment of patients with PTSD?" the advisers voted 10 "no" to 1 "yes" against MDMA. The one expert who voted "yes" said afterward that his confidence in that vote was low.

The votes come after a full-day meeting in which the independent expert advisers heard detailed reviews of clinical trial data from the company that proposed the therapy—Lykos, formerly MAPS—as well as internal FDA reviews.

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